Numen
GUDID 06958698011409
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil| Primary Device ID | 06958698011409 |
| NIH Device Record Key | 43d290dc-1346-43c1-86a7-23bcdbbe1ba3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Numen |
| Version Model Number | 3D3H06FN |
| Company DUNS | 551973856 |
| Company Name | MicroPort NeuroTech (Shanghai) Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06958698011409 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203625
FDA Product Code
| HCG | Device, Neurovascular Embolization |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-23 |
| Device Publish Date | 2022-03-15 |
On-Brand Devices [Numen]
| 06958698011676 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011669 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011652 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011645 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011638 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011621 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011614 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011607 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011591 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011584 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011577 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011560 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011553 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011546 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011539 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011522 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011515 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011508 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011492 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011485 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011478 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011461 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011454 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011447 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011430 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011423 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011416 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011409 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011393 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011386 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011379 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011362 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011355 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011348 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011331 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011324 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011317 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011300 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011294 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011287 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011270 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011263 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011256 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011249 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011232 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011225 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011218 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011201 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011195 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
| 06958698011188 | The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detach |
Trademark Results [Numen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUMEN 97863636 not registered Live/Pending |
Clovertex Inc. 2023-03-29 |
 NUMEN 79315348 not registered Live/Pending |
MicroPort NeuroTech (Shanghai) Co.,Ltd. 2021-03-31 |
 NUMEN 79190894 5248142 Live/Registered |
Ecocentric Group Limited 2015-12-24 |
 NUMEN 79188899 5253101 Live/Registered |
Ecocentric Group Limited 2015-12-24 |
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